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Lesions of the LiverPhase 2/3NCT00280410

Study Investigating the Effect of E7337 on Tumor Like Lesions in Computed Tomography (CT) of the Liver

A Phase 2/3 study testing E7337 in people with Lesions of the Liver, run by Eisai Inc. at 14 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a multicenter, randomized, open-label study to investigate the superiority of the contrast enhancement effect of E7337 on tumor-like lesions in the Dynamic CT of the liver. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Lesions of the Liver
What is being tested?
E7337
How many people
192 participants
Where
14 sitesJapan
Study dates
Feb 2006to Oct 2006
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a tumorous lesion in the liver observed in diagnostic imaging such as ultrasonography, etc., conducted between 1 and 35 days before administration of the investigational agent, who are scheduled to undergo a dynamic CT examination.
  • Patients between 20 and 80 years old at the time informed consent is obtained.
  • Patients weighing >= 55.6 and < 105.0 kg at the time consent is obtained and when the investigational agent is administered.
  • Exclusion Criteria:Issues affecting the safety evaluation of the investigational agent:
  • Patients who will have undergone or are scheduled to undergo an examination using another contrast agent from 7 days before administration of the investigational agent up to the time follow-up examinations are performed on day 8 after administration.
  • Patients for whom there is a strong possibility that a follow-up period, which extends up until examinations are performed on day 8 after administration, would not be possible, (i.e., when it will not be possible to evaluate delayed adverse drug reactions).
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  • Patients who have undergone or are scheduled to undergo surgical treatment or a therapy such as percutaneous ethanol injection therapy, percutaneous microwave coagulation therapy, radiofrequency ablation, or transcatheter arterial embolization, etc., from the time diagnostic imaging such as abdominal ultrasonography is performed up until follow-up examinations are conducted on day 8 after administration.
  • Patients who are unable to discontinue taking analgesics during the period from the morning when the investigational agent is administered until CT examinations are completed.
  • Patients who cannot stop taking biguanide antidiabetic drugs, such as metformin hydrochloride and buformin hydrochloride, for three days after study agent administration (including administration day).
  • Patients who are currently participating in another clinical study.
  • Patients who participated in another clinical study within the 6 months prior to providing informed consent to participate in this study.
  • General concerns relating to the safety of the subject:
  • Patients in the acute stage of illness with unstable symptoms, or patients in a life-threatening condition (when it is expected that emergency treatment may be required between the time of registration and the conclusion of the follow-up period, or when the patient is not expected to survive for 3 months following administration of the investigational agent, etc.)
  • Patients with a history of hypersensitivity to iodine or iodinated contrast agents.
  • Patients with serious thyroid disease (goiter, hyperthyroidism, etc.)
  • Patients with serious cardiopathy (New York Heart Association [NYHA] functional class IV heart failure, shock, cyanosis, peripheral circulatory insufficiency, ventricular tachycardia, ventricular fibrillation, or complete atrioventricular block)
  • Patients with serious hepatopathy [symptoms of liver failure (fulminant hepatitis) such as a disturbance of consciousness corresponding to grade 3 in the Criteria for Grading Adverse Drug Reactions of Medicinal Products.]
  • Patients with moderate serious nephropathy (acute kidney failure, chronic kidney failure, hydronephrosis, nephrotic syndrome, or uremia with serum creatinine levels of 2.0 mg/dL or more, corresponding to grade 2 or above in the Criteria for Grading Adverse Drug Reactions of Medicinal Products.)
  • Patients with bronchial asthma
  • Patients with acute pancreatitis
  • Patients with macroglobulinemia
  • Patients with multiple myeloma
  • Patients with tetany
  • Patients with pheochromocytoma or who are suspected of having pheochromocytoma
  • Pregnant and potentially pregnant women, and nursing mothers
  • Patients with a history of medicine hypersensitivity
  • Patients with serious myasthenia gravis
  • Patients judged by an investigator for any other reason to be ineligible for participation as a subject in this study.

Who cannot join

None listed.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Japan14 sites

  • Study site

    Fukuoka, Fukuoka, 810-0065

  • Study site

    Fukushima, Fukushima

  • Study site

    Isehara, Kanagawa

  • Study site

    Kanazawa, Ishikawa-ken

  • Study site

    Kashihara, Nara

  • Study site

    Kobe, Hyōgo

  • Study site

    Kumamoto, Kumamoto

  • Study site

    Minato-ku, Tokyo

  • Study site

    Okayama, Okayama-ken

  • Study site

    Sapporo, Hokkaido

  • Study site

    Sayama, Osaka

  • Study site

    Shinagawa-ku, Tokyo

  • Study site

    Shinjuku-ku, Tokyo

  • Study site

    Suita, Osaka

Other trials in Japan

About this study

Official title: Multicenter, Randomized, Open-Label Study Investigating The Superiority Of The Contrast Enhancement Effect Of E7337 On Tumor Like Lesion In The Dynamic CT Of The Liver Of Patients With Tumor Like Lesions In The Liver

This is a multicenter, randomized, open-label study to investigate the superiority of the contrast enhancement effect of E7337 on tumor-like lesions in the Dynamic CT of the liver.

Being tested
E7337

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E7337Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Contrast enhancement effect on tumor-like lesions in the liver.

Secondary outcomes (1)

  1. Contrast enhancement effect (amount of change in CT value) on the portal venous phase (portal vein, left and right lobes of the liver parenchyma). Contrast enhancement effect on the arterial phase (hepatic artery).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionOct 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
192 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00280410
Sponsor's protocol ID
E7337-J081-151
Status last verified
Jan 2010
First submitted
20 Jan 2006
Last updated
29 Jan 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing E7337 in people with Lesions of the Liver, run by Eisai Inc. at 14 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Contrast enhancement effect on tumor-like lesions in the liver.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00280410.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2010.

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